A Study Of Early Markers Of Choroidal Neovascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902785
Recruitment Status : Terminated
First Posted : May 15, 2009
Last Update Posted : November 10, 2010
Information provided by:

Brief Summary:
Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient with CNV in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention.

Condition or disease Intervention/treatment
Choroidal Neovascularization (CNV) Age-related Macular Degeneration (AMD) Early Markers Other: no drug

Detailed Description:
CNV in one eye and dry AMD in the other

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Two-Year Exploratory, Observational, Non-Interventional Multicenter Study To Identify Early Markers Of Choroidal Neovascularization In Fellow Eyes Of Patients With Neovascular AMD In One Eye
Study Start Date : March 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
no drug
no drug
Other: no drug
observational no drug

Primary Outcome Measures :
  1. Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD. [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • age-related macular degeneration (AMD)
  • choroidal neovascularization (CNV)

Inclusion Criteria:

  • Sub-, extra- or juxta-foveal choroidal neovascularization (CNV) or macular scar due to AMD in the non-study eye.
  • No CNV or geographic atrophy in the study eye.
  • Best corrected visual acuity in the study eye of greater than 20/40 or better than 70 ETDRS letters.
  • Sufficiently clear ocular media and adequate pupillary dilatation to permit good quality fundus imaging of the study eye.
  • Subjects of either sex, aged 50 years.
  • Evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
  • Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures.

Exclusion Criteria:

  • Subjects presenting with any of the following will not be included in the study:
  • Evidence of manifest CNV by FA, color photography or ICG angiography in the study eye.
  • Any prior treatment for CNV to the study eye (excluding vitamins and AREDS formula).
  • Significant media opacities, including cataract, which might interfere with visual acuity assessments, or fundus imaging in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years.
  • Presence of other causes of choroidal neovascularization in the fellow eye, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
  • Any progressive eye disease other than AMD (eg, glaucoma, diabetic retinopathy) in the study eye.
  • Presence of subretinal hemorrhage, serous or hemorrhagic pigment epithelial detachments, subretinal fibrosis or pigment epithelial tears or rips in the study eye.
  • Any medical condition that would interfere with the patient's ability to complete the trial.
  • Concurrent enrollment in any other observational or interventional clinical study.
  • Any treatment with an ocular or systemic investigational agent in the past 60 days for any medical condition.
  • Known serious allergies to the dye used in fluorescein angiography or ICG.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00902785

Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Coimbra, Portugal, 3000-354
United Kingdom
Pfizer Investigational Site
Belfast, United Kingdom, BT12 6BA
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00902785     History of Changes
Other Study ID Numbers: A9011051
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: November 2010

Keywords provided by Pfizer:
non-interventional study age-related macular degeneration (AMD) choroidal neovascularization (CNV)

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases